A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,230

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

December 31, 2006

Study Completion Date

October 31, 2011

Conditions
Psoriasis
Interventions
DRUG

Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg

Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264

DRUG

Ustekinumab (CNTO 1275) 45 mg

Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264

DRUG

Ustekinumab (CNTO 1275) 90 mg

Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264

Trial Locations (62)

Unknown

Birmingham

Little Rock

La Jolla

Los Angeles

San Diego

Jacksonville

Miami

Normal

Skokie

Indianapolis

Louisville

Andover

Boston

Port Huron

St Louis

Las Vegas

New Brunswick

New York

Winston-Salem

Cleveland

Portland

Philadelphia

Plymouth Meeting

Mt. Pleasant

Nashville

Houston

San Antonio

Salt Lake City

Graz

Innsbruck

Vienna

Calgary

Edmonton

Surrey

Vancouver

Moncton

Halifax

Barrie

Hamilton

London

North Bay

Toronto

Waterloo

Windsor

Montreal

Sainte-Foy

Sherbrooke

Nice

Berlin

Brandenburg

Dresden

Erlangen

Frankfurt

Hamburg

Kiel

Mainz

München

Geneva

Zurich

London

Salford

Southampton Trials Carried Out

All Listed Sponsors
lead

Centocor Research & Development, Inc.

INDUSTRY

NCT00307437 - A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis | Biotech Hunter | Biotech Hunter